A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152) (SKYSCRAPER-14)

A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic HCC.

Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus tiragolumab arm are recommended to discontinue tiragolumab treatment unless the investigator decides the benefit outweighs the risk. Participants receiving treatment in atezolizumab plus bevacizumab plus placebo arm must discontinue placebo treatment. Participants may continue receiving active treatment(s) per protocol until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Tiragolumab; Other: Placebo; Drug: Atezolizumab; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 687
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Rumbeke)
• Brazil
  • Rio de Janeiro, Brazil, 22290-160
    • Clinicas Oncologicas Integradas - COI
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055-450
      • CEDOES - Diagnóstico e Pesquisa
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30170-080
      • Oncoclínicas do Brasil - BELO HORIZONTE
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50040-000
      • Hospital do Cancer de Pernambuco - HCP
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Hospital de Cancer de Barretos
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site
• China
  • Baoji, China, 721008
    • Baoji Central Hospital
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410013
    • Hunan Cancer Hospital
  • Changsha, China, 410007
    • Peoples Hospital of Hunan Province
  • Chengdu, China, 610047
    • West China Hospital - Sichuan University
  • Fuzhou, China, 350025
    • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangzhou, China
    • Sun Yat-sen University Cancer Center
  • Guangzhou, China, 510515
    • Nanfang Hospital, Southern Medical University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Hangzhou, China, 310014
    • Zhejiang Provincial People?s Hospital
  • Harbin, China, 150081
    • Harbin medical university cancer hospital
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Hefei, China, 230601
    • The Second Affiliated Hospital of Anhui Medical University
  • Lishui, China, 323000
    • Lishui Central Hospital
  • Shanghai, China, 200127
    • Renji Hospital Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan Unvierstiy
  • Shenyang, China, 110004
    • Shengjing Hospital Of China Medical University
  • Tianjin, China, 300060
    • Tianjin cancer hospital
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Xi'an, China, 710119
    • Xi'an Inernational Medical Center Hospital
• Côte d’Ivoire
  • Abidjan, Côte d’Ivoire, BP 1463 Abidjan
    • Polyclinique Internationale Sainte Anne- Marie (PISAM)
  • Abidjan, Côte d’Ivoire
    • Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO)
• France
  • Caen, France, 14033
    • Chu Caen - Hôpital de La Côte de Nacre
  • Lille, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Limoges, France, 87042
    • Hôpital Dupuytren
  • Marseille, France, 13285
    • Fondation Hôpital Saint Joseph
  • Nantes, France, 44093
    • Hopital Hotel Dieu Et Hme
  • Paris, France, 75571
    • APHP - Hôpital Saint Antoine
  • Reims, France, 51092
    • Hôpital Robert Debré
  • Valence, France, 26953
    • Centre Hospitalier Valence
  • Vandœuvre-lès-Nancy, France, 54511
    • Hopitaux de Brabois - Gastro-Entereologie
  • Villejuif, France, 94804
    • Hopital Paul Brousse
• Germany
  • Esslingen am Neckar, Germany, 73730
    • Klinikum Esslingen
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie
  • Mainz, Germany, 55131
    • Uniklinik Mainz
  • Tübingen, Germany, 72076
    • Universitat Tubingen
• Ghana
  • Accra, Ghana, 0000
    • KBTH
  • Accra, Ghana
    • Sweden Ghana Medical Center
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Shatin, Hong Kong
    • Prince of Wales Hosp
• Italy
  • Apulia
    • Tricase, Apulia, Italy
      • Az. Osp. G. Panico
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O. S. Orsola Malpighi
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Az. Osp. Uni Ria San Martino
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • A.O.U. Policlinico Paolo Giaccone
  • Veneto
    • Verona, Veneto, Italy, 37134
      • A.O.U.I. Verona-Ospedale Policlinico G.B. Rossi Borgo Roma
• Japan
  • Aichi, Japan, 470-1192
    • Fujita Health University Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Ehime, Japan, 790-0024
    • Ehime Prefectural Central Hospital
  • Fukuoka, Japan, 830-0011
    • Kurume University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido, Japan, 060-8648
    • Hokkaido University Hospital
  • Hokkaido, Japan, 060-0033
    • Sapporo Kosei General Hospital
  • Ishikawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kanagawa, Japan, 252-0375
    • Kitasato University Hospital
  • Kanagawa, Japan, 213-8587
    • Toranomon Branch Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Numakunai, Japan, 028-3695
    • Iwate Medical University Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Japan, 565-0871
    • The University of Osaka Hospital
  • Tochigi, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokyo, Japan, 180-8610
    • Japanese Red Cross Musashino Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
• Kenya
  • Nairobi, Kenya
    • University of Nairobi - Institute of Tropical and Infectious Diseases
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06720
      • Centro Medico Nacional Siglo Xxi - Imss
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • OncoMed
    • Mexico City, Mexico CITY (federal District), Mexico, 14000
      • Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán
  • Oaxaca
    • Oaxaca City, Oaxaca, Mexico, 68020
      • Centro de Investigacion Clinica de Oaxaca
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Wellington, New Zealand, 6021
    • Wellington Hospital
• Nigeria
  • Jos, Nigeria, 930232
    • Jos University Teaching Hospital
  • Lagos, Nigeria
    • Lagos University Teaching Hospital Lagos (LUTH), Lagos State
• Poland
  • Mysłowice, Poland, 41-400
    • ID Clinic
  • Warsaw, Poland, 02-034
    • NIO im Marii Sklodowskiej-Curie
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • PanOncology Trials
• Singapore
  • Singapore, Singapore, 168583
    • National Cancer Centre
• South Africa
  • Johannesburg, South Africa, 2193
    • Charlotte Maxeke Johannesburg Academic Hospital
  • Polokwane, South Africa, 0700
    • Limpopo Cancer Research Institute
• South Korea
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 003-722
    • Severance Hospital, Yonsei University Health System
  • Ulsan, South Korea, 44033
    • Ulsan University Hosiptal
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08907
    • Hospital Duran i Reynals
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain, 28027
    • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Navarre
    • Navarra, Navarre, Spain, 31008
      • Hospital de Navarra
    • Pamplona/iruña, Navarre, Spain, 31008
      • Clinica Universitaria de Navarra
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Tainan, Taiwan, 00704
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 710
    • Chi-Mei Medical Centre
  • Taipei, Taiwan, 100
    • National Taiwan Uni Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Khon Kaen, Thailand, 40002
    • Khon Kaen Uni
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01220
    • Adana Baskent University Medical Faculty
  • Ankara, Turkey (Türkiye), 06490
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 06500
    • Gazi Uni Medical Faculty Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Kar?iyaka, Turkey (Türkiye), 35575
    • ?zmir Medical Point
• Uganda
  • Kampala, Uganda
    • Uganda Cancer Institute
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Clovis, California, United States, 93611
      • UCSF Fresno at Community Cancer Institute
    • Duarte, California, United States, 91010
      • City of Hope Cancer Center
    • La Jolla, California, United States, 92037
      • University of California San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Center
    • Santa Monica, California, United States, 90404
      • UCLA Cancer Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Healthcare Cancer Institute at Hartford Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hosp Center
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists - Fort Myers (Broadway)
    • Miami, Florida, United States, 33125
      • Miami VA Healthcare System
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialist, North Region
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Norton Cancer Institute - Audubon
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Cancer Inst.
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers of Western Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology Woodbury
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington Uni School of Medicine
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032-3725
      • Columbia University
    • New York, New York, United States, 10016
      • NYU Langone
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • The Bronx, New York, United States, 10468
      • James J Peters VA Hospital / Mental Illness Research Education and Clinic Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Uni
  • Texas
    • Dallas, Texas, United States, 75216
      • North Texas VA Medical Center
    • Houston, Texas, United States, 77005
      • Kelsey Seybold Clnic
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Inst.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Univ of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
• Disease that is not amenable to curative surgical and/or locoregional therapies
• No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC-measurable disease according to RECIST v1.1
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1 within 7 days prior to randomization
• Child-pugh Class A within 7 days prior to randomization
• Adequate hematologic and end-organ function
• Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
• Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.

Exclusion Criteria:

• Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
• Treatment with systemic immunostimulatory agents
• Treatment with systemic immunosuppressive medication
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
• Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
• Acute epstein-barr virus (EBV) infection or known or suspected chronic active EBV infection
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab + Bevacizumab + Tiragolumab; Atezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.	Drug: Tiragolumab; Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle.; Other Names: MTIG7192A; RO7092284; Drug: Atezolizumab; Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle.; Other Names: Tecentriq; MPDL3280A; RO5541267; Drug: Bevacizumab; Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle.; Other Names: Avastin
Placebo Comparator: Atezolizumab + Bevacizumab + Placebo; Atezolizumab, bevacizumab plus placebo will be administered Q3W until unacceptable toxicity or loss of clinical benefit as determined by the investigator.	Other: Placebo; Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.; Drug: Atezolizumab; Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle.; Other Names: Tecentriq; MPDL3280A; RO5541267; Drug: Bevacizumab; Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle.; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	From randomization to death from any cause (up to approximately 36 months)
Investigator-assessed Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	From randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first (up to approximately 21 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS Rate at 1 and 2 Years		Year 1, Year 2
Investigator-assessed Confirmed Objective Response Rate (ORR) According to RECIST v1.1		From randomization up to approximately 21 months
Investigator-assessed Duration of Response (DOR) According to RECIST v1.1		From the first occurrence of a documented confirmed objective response to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months)
Investigator-assessed PFS Rate According to RECIST v1.1 at 6 and 12 Months		Month 6, Month 12
Investigator-assessed PFS According to HCC mRECIST		From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months)
Investigator-assessed Confirmed ORR According to HCC mRECIST		From randomization up to approximately 21 months
Investigator-assessed DOR According to HCC mRECIST		From the first occurrence of a documented confirmed objective response to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months)
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30 (EORTC QLQ-C30) Subscales	The following subscales of the EORTC QLQ-C30 will be used for the assessment: global health status/quality-of-life (GHS/QoL), physical functioning and role functioning. GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome.	Up to approximately 21 months
Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30	GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome.	Up to approximately 21 months
Percentage of Participants With Adverse Events (AEs)		Up to approximately 36 months
Serum Concentrations of Atezolizumab		Prior to the first infusion and 30 minutes after atezolizumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)
Serum Concentrations of Tiragolumab		Prior to the first infusion and 30 minutes after tiragolumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab		Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)
Percentage of Participants With ADAs to Atezolizumab		Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Chugai Pharmaceutical
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Badhrinarayanan S, Cotter C, Zhu H, Lin YC, Kudo M, Li D. IMbrave152/SKYSCRAPER-14: a Phase III study of atezolizumab, bevacizumab and tiragolumab in advanced hepatocellular carcinoma. Future Oncol. 2024;20(28):2049-2057. doi: 10.1080/14796694.2024.2355863. Epub 2024 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): May 8, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; atezolizumab; Tiragolumab
• Other Study ID Numbers: CO44668; 2023-503422-39-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No